UV Dosimetry Feedback in NMSC Patients

UV Dosimetry Feedback in Non-Melanoma Skin Cancer Patients

This study aims to characterize UV exposures among NMSC patients (those with a history of skin cancer) and to pilot an innovative behavioral intervention to decrease modifiable UV exposures. It will use UV dosimeters to objectively measure UV exposure and provide time and activity specific UV data on an individual level. These data will be used to develop a targeted and personalized behavioral feedback plan with counseling aimed at effective sun exposure behavior change

Study Overview

• Status: Withdrawn
• Conditions: Non-Melanoma Skin Cancer
• Intervention / Treatment: Behavioral: UV Counseling

Detailed Description

The study will focus on helping to prevent NMSC and its associated morbidity through learning when patients are unintentionally exposed to extreme UV radiation. It will then help to create manageable and realistic behavioral interventions to reduce exposure, while also educating patients of the dangers of abundant sun exposure.

• Study Type: Interventional
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Colorado
    • Aurora, Colorado, United States, 80045
      • University of Colorado

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 50 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Patients between ages 18 and 50.
• Must be diagnosed with non-melanoma skin cancer.

Exclusion Criteria:

• Patients, who at the discretion of the clinician, are too ill or sick.
• Non-English speaking patients.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: UV Dosimeter; UV Dosimeter will measure participants' UV exposure for two separate 3-week periods.	Behavioral: UV Counseling; Participants will self-report their knowledge and attitudes related to UV exposure. They will then wear a dosimeter for 3 weeks. After, the study team will counsel the participants on their UV levels and exposure, creating a personal plan and advice for avoiding sun exposure before letting the participants wear the dosimeter for an additional 3 weeks.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Identify Discrepancies of Self-Reported Sun Exposure and Actual Sun Exposure	Measured using individual dosimeters and comparing it to what participants state they believe their level of sun exposure is	Start of study to end of study, up to 3 months
Identify Discrepancies of Self-Reported Sun Exposure and Actual Sun Exposure	Compare specific sun exposure behaviors responsible for the level of exposure versus what could be done to lessen it	Start of study to end of study, up to 3 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Behavioral Intervention and immediate follow-up	Participants will receive a personalized feedback plan and the success of the plan will be measured through individual dosimetry. We will track real time change in sun exposure based on repeat UV dosimetry.	Start of study to end of study, up to 3 months
Long Term Follow Up - longitudinal change in sun exposure based on dosimetry	Track the longitudinal change in sun exposure comparing baseline UV dosimetry measurements to 3 month follow up dosimetry measurements to determine if the changes observed in outcome 3 are maintained.	Start of study to end of study, up to 3 months

Collaborators and Investigators

• Sponsor: University of Colorado, Denver
• Investigators: Principal Investigator: Myles Cockburn, PhD, University of Colorado, Denver

Study record dates

Study Major Dates

• Study Start (Actual): March 12, 2018
• Primary Completion (Actual): August 30, 2019
• Study Completion (Actual): August 30, 2019

Study Registration Dates

• First Submitted: November 26, 2018
• First Submitted That Met QC Criteria: November 26, 2018
• First Posted (Actual): November 29, 2018

Study Record Updates

• Last Update Posted (Actual): September 6, 2019
• Last Update Submitted That Met QC Criteria: September 4, 2019
• Last Verified: September 1, 2019

More Information

Terms related to this study

• Keywords: Behavioral; Self-Regulation; Social Cognitive Theory; Self-Efficacy; UV Dosimetry; UV Exposure
• Additional Relevant MeSH Terms: Skin Diseases; Neoplasms; Neoplasms by Site; Skin Neoplasms
• Other Study ID Numbers: 17-2134.cc

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No